Deployment handle for a delivery device with mechanism for quick release of a prosthesis and re-sheathing of device tip

ABSTRACT

The present invention relates to a prosthesis delivery device and to a handle assembly at the distal end of the delivery device. The handle assembly comprises a main handle and a nut disposed on the main handle. The nut comprises a first configuration in which the nut is engaged with the outer surface of the main handle and a second configuration in which the nut is disengaged from the outer surface of the main handle. Disengaging the nut from the main handle facilitates quick sheath retraction and deployment of at least the distal end of the prosthesis as well as recapturing the proximal end of the device within the sheath.

RELATED APPLICATIONS

This application claims the benefit of U.S. provisional application Ser.No. 62/097,244 filed on Dec. 29, 2014, which is incorporated herein byreference in its entirety.

TECHNICAL FIELD

The present invention relates to a deployment handle assembly for aprosthesis delivery device. The deployment handle assembly comprises amechanism that facilitates quick release of the prosthesis from thedelivery device as well as re-sheathing of the tip of the deliverydevice for removal of the device from a patient's body.

BACKGROUND

The use of delivery devices or introducers employing catheters has longbeen known for a variety of medical procedures, including procedures forestablishing, re-establishing or maintaining passages, cavities orlumens in vessels, organs or ducts in human and veterinary patients,occlusion of such vessels, delivering medical treatments, and otherinterventions. For these procedures, it has also long been known todeliver an implantable medical device by means of a catheter, oftenintraluminally. For example, a stent, stent-graft, vena cava filter orocclusion device may be delivered intraluminally from the femoral arteryfor deployment.

For procedures in which a prosthesis or other medical device isimplanted into a patient, the prosthesis to be implanted is normallyheld on a carrier catheter or cannula of the introducer in a compressedstate and then released from the carrier catheter so as to expand to itsnormal operating state, prior to withdrawal of the catheter from thepatient to leave the prosthesis in position. In many devices, the stepsto carry out the implantation may occur, for example, first byretracting a retractable sheath to expand or partially expand theprosthesis, and then performing further steps to, for example, releaseone or both ends of the prosthesis, deploy an anchoring stent, or thelike. In most cases, it is desirable that such deployment steps follow aspecific order as instructed by the manufacturer of the device. Forexample, deployment of the proximal end may be performed in a slower andmore controlled manner to ensure accurate deployment in a preciselocation, whereas it may be desirable to release and deploy the distalend of the prosthesis more quickly. Once the prosthesis has beenproperly and fully deployed within a patient, it may be desirable tocover a prosthesis release mechanism and/or the proximal tip of thedelivery device before removing the delivery device from thevasculature. Thus, the delivery device described herein comprises ahandle assembly that permits quick release of at least a portion of theprosthesis from the delivery device as well as re-sheathing of theprosthesis release mechanism and the tip of the delivery device forremoval from a patient's body.

SUMMARY

The present invention relates to a prosthesis delivery device having aproximal end and distal end and a handle assembly at the distal end ofthe delivery device. In one example, the handle assembly comprises amain handle having a proximal end and a distal end and an outer surfaceextending between the proximal and distal ends. A nut is disposed on theouter surface of the main handle. The nut comprises a firstconfiguration in which the nut is engaged with the outer surface of themain handle and a second configuration in which the nut is disengagedfrom the outer surface of the main handle. A sleeve is disposed about atleast a portion of the nut and longitudinally moveable relative to thenut from a proximal position to a distal position. When the sleeve is inthe proximal position the nut is engaged with the outer surface of themain handle and when the sleeve is in the distal position the nut isdisengaged from the main handle.

In another example, a method for releasing a prosthesis from a deliverydevice is disclosed. The delivery device comprising a prosthesisreleasably coupled to the proximal end of the delivery device, a sheathcoaxially disposed about at least a portion of the prosthesis and adelivery handle assembly at a distal end of the delivery device. Thedelivery handle assembly comprising a main handle, a second handledisposed about the main handle and operatively connected to the sheath,a nut disposed on an outer surface of the main handle, the nutcomprising a first configuration in which the nut is engaged with theouter surface of the main handle and a second configuration in which thenut is disengaged from the outer surface of the main handle. In oneexample, the method comprises rotating the second handle to at leastpartially retract the sheath and expose at least a proximal end of theprosthesis, deploying at least the proximal end of the prosthesis,disengaging the nut from the main handle, retracting the second handledistally relative to the main handle to further retract the sheath andexpose a distal end of the prosthesis and deploying the distal end ofthe prosthesis.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a prosthesis delivery device with anexample of a handle assembly at the distal end and a prosthesis retainedbeneath a sheath at the proximal end.

FIG. 2 is a side cross sectional view of the handle assembly of FIG. 1.

FIG. 3 is an exemplary stent graft that may be delivered and deployedwithin the vasculature of a patient.

FIG. 4 is a side view of the proximal end of the delivery device withthe proximal stent of a stent graft held in a radially inward contractedconfiguration on the delivery device by a prosthesis retentionmechanism.

FIG. 5 is a side view of the proximal end of the delivery device withthe proximal stent of a stent graft released from the retentionmechanism and deployed in a radially outwardly expanded configuration.

FIG. 6 is a side view of the proximal end of the delivery device.

FIG. 7 is an enlarged view of FIG. 6 showing one example of a stentgraft attachment and release mechanism at the proximal end of thedelivery device.

FIG. 8 is a front perspective view of a sheath connector component ofthe handle assembly.

FIG. 9 is a perspective view of a portion of the main handle of thehandle assembly.

FIG. 10 is a sectional view of the second handle of the handle assembly.

FIG. 11 is an enlarged view of the proximal end of the handle assemblywith a portion of the second handle removed.

FIG. 11A is a perspective view of one example of a nut mechanism withinthe handle assembly.

FIG. 12 is a perspective view of the handle assembly with a portion ofthe second handle and outer ring removed.

FIG. 13 illustrates the delivery device being tracked to a desiredlocation within a patient's vasculature during delivery and deploymentof a stent graft.

FIG. 13A is an enlargement of the distal end of a stent graft carried onthe delivery device with the stents in a radially inward contractedconfiguration under a sheath.

FIG. 14 is a perspective view of one example of the handle assembly.

FIG. 15 illustrates the delivery device being tracked to a desiredlocation within a patient's vasculature with the sheath retracted toexpose a proximal end of the stent graft during delivery and deploymentof a stent graft.

FIG. 16 is a cross sectional view of one example of the handle assemblywith the second handle moved distally relative to the main handle toexpose a prosthesis release actuation mechanism, or proximal suturedrum.

FIG. 17 is a cross sectional view of one example of a proximal suturedrum.

FIG. 18 is a partial sectional view of the interior of the handleassembly showing a suture extending between a proximal suture drum and amotion translating mechanism, or distal suture drum.

FIG. 19 is a cross sectional view of the distal end of the handleassembly showing the distal suture drum.

FIG. 20 is a perspective view of the distal end of the main handle andthe distal suture drum.

FIG. 21 is an enlarged perspective view of one example of a distalsuture drum and a suture wrapped about the distal suture drum.

FIG. 22 is an enlarged perspective view of the proximal end of oneexample of the handle assembly with a suture wrapped about a portion ofthe main handle.

FIG. 23 is a perspective view of one example of the handle assembly withthe second handle moved distally relative to the first handle to retractthe sheath and thereby expose a portion of the stent graft duringdelivery and deployment.

FIG. 24 illustrates the delivery device within a patient's vasculaturewith the sheath further retracted to expose the main body of the stentgraft and contralateral leg during delivery and deployment of a stentgraft.

FIG. 25 illustrates the delivery device within a patient's vasculatureand the stent graft partially deployed, with a leg extension graft beingtracked into the contralateral leg of the stent graft.

FIG. 26 is a side cross sectional view of the handle assembly showingrotation of the proximal suture drum effecting rotation of the distalsuture drum and inner cannula to release a proximal stent.

FIG. 27 illustrates the delivery device within a patient's vasculaturewith the sheath further retracted to expose the ipsilateral limb.

FIG. 28 A is a perspective view of the handle assembly of FIG. 23,before the ipsilateral limb has been deployed.

FIG. 28 B is a perspective view of the handle assembly of FIG. 28A witha portion of the second handle and outer ring removed to illustrate thesleeve in a distal position and the nut disengaged from the main handle.

FIG. 29 A is a perspective view of the handle assembly with the secondhandle fully retracted relative to the main handle to effect deploymentof the ipsilateral limb.

FIG. 29 B is a perspective view of the handle assembly of FIG. 29A witha portion of the second handle and outer ring removed to illustrate thesleeve in a distal position and the nut disengaged from the main handle.

FIG. 30 is a cross sectional view of the distal end of one example ofthe handle assembly showing the distal trigger wire knob, distal suturedrum and a distal flush hub.

FIG. 31 is a side view of one example of a nut and a sleeve in aproximal position retaining the nut into engagement with the mainhandle.

FIG. 31A is a perspective view of one example of a sleeve.

FIG. 32 is a side view of one example of a nut with the sleeve moveddistally causing the nut to flare radially outwardly and disengage fromthe main handle.

FIG. 33 is a perspective view of another example of the handle assemblyincluding a rack, with a portion of the second handle removed to showanother example of a proximal suture drum.

FIG. 34 is a perspective view of the handle assembly of FIG. 33 showingthe second handle moved distally relative to the main handle, therebyexposing the proximal suture drum.

FIG. 35 is a side view of the handle assembly of FIG. 33 showing therack within the main handle.

FIG. 36 is an enlarged perspective view of the rack within the mainhandle of FIG. 33.

FIG. 37 is an enlarged perspective view of the rack within the mainhandle of FIG. 36.

FIG. 38 is a perspective view of another example of the proximal suturedrum in the handle of FIGS. 33-37.

FIG. 39 is a perspective view of one example of a stent graft carried atthe proximal end of the delivery device with the proximal stent capturedby a proximal retention mechanism and on example of a distal retentionmechanism securing the ipsilateral limb to the delivery device.

FIG. 40 is an enlarged view of the distal retention mechanism of FIG.39.

FIG. 41 is another example of a distal retention mechanism.

FIG. 42 is another example of a distal retention mechanism.

FIG. 43 is a perspective view of a prosthesis delivery device with anexample of a handle assembly at the distal end with a portion of thehandle removed to show the nut engaged with the main handle and aprosthesis retained beneath a sheath at the proximal end of the device.

FIG. 44 is a perspective view of a prosthesis delivery device with thesecond handle retracted distally on the main handle, the sheathretracted and the stent graft deployed and released from the deliverydevice.

FIG. 45 is a perspective view of the delivery device with the proximaltip re-sheathed and configured for withdrawal of the device from apatient.

DETAILED DESCRIPTION

In this description, when referring to a prosthesis delivery device,proximal refers to the part of the delivery device that is furthest fromthe operator and intended for insertion in a patient's body and distalrefers to that part of the delivery device closest to the operator. Withregard to the prosthesis, the term proximal refers to that part of theprosthesis that is closest to the proximal end of the delivery deviceand distal refers to the opposite end of the prosthesis.

In general and described in more detail below with reference to thereference numbers and figures, the delivery device 2 includes a proximalend 4 and a distal end 6. A handle assembly 8 is located adjacent thedistal end of the device. One example of a handle assembly 8, isdescribed in detail below and also described in U.S. Provisional patentapplication 62/074,766 filed Nov. 4, 2014, entitled “Deployment HandleFor A Prosthesis Delivery Device”, which is incorporated by referenceherein in its entirety. Handle assembly 8 generally includes first ormain handle 10 and a second or outer handle 12 and an end cap 14. Themain handle 10 is fixed relative to the delivery device 2 and the secondhandle 12 is disposed on the main handle 10 and is movablelongitudinally and/or circumferentially relative to the main handle.

A mechanism within the handle assembly 8 permits the user to implement a“quick release” deployment procedure in which at least a distal portionof a prosthesis can be easily and quickly released from the deliverydevice 2 and deployed within the patient's vasculature if necessaryand/or desired. When deployment of the prosthesis is complete, this samequick release mechanism within the handle assembly 8 may also facilitatere-sheathing or “hubbing” of the proximal end of the delivery device 2,to facilitate removal of the delivery device from the patient's tortuousvasculature.

In one non-limiting example, this mechanism within the handle assembly 8that facilitates quick release of a prosthesis and/or re-sheathing ofthe proximal end 4 of the delivery device 2 may comprise a nut 142within the second handle 12. When the nut 142 is in a radially inwardlycontracted condition, it engages the main handle 10, and in a radiallyoutwardly flared condition, it becomes disengaged from the main handle10 to facilitate the quick release deployment procedure and/orre-sheathing of the proximal end 4 of the delivery device 2. Otherfeatures of the delivery device 2, and in particular the handle assembly8 comprising the flared nut mechanism 142 are described more fullybelow. One of skill in the art will recognize that the flared nutmechanism as described herein may be incorporated into and/or used witha variety of prosthesis delivery devices and a variety of handleassemblies, and is not limited to use with the handle assemblies and/ordelivery devices described herein.

As shown in FIGS. 1, 4 and 5, the proximal end 4 of the delivery device2 includes stent graft retention region 16 and a tapered nose conedilator 18 having a proximal tip 20. An inner cannula 22 extends thelongitudinal length of the delivery device 2, from a distal flush hub 24at the distal end 6 of the device 2 to the tapered nose cone dilator 18at the proximal end 4 of the device 2. Inner cannula 22 has an innerlumen 26 which may accommodate a guide wire 28 for tracking the deliverydevice 2 to a desired position within a patient's vasculature and whichmay be used for flushing or injection of fluids. The inner cannula 22may be made of a variety of suitable materials including a flexiblematerial, polymer, metal and/or alloy, for example nitinol or stainlesssteel, and may be either straight or have a curve imparted to a portionof it.

A stiffening cannula or positioner 30 may be disposed over at least aportion of the inner cannula 22. The positioner 30 may be constructedfrom various materials, and in one example, a proximal portion 32 of thepositioner which is introduced into the patient may comprise a polymer,sometimes referred to as VRDT (or vinyl radiopaque dilator tubing),plastics, metals, alloys or a combination thereof, whereas a distalportion 34 of the positioner 30 may comprise the same material as theproximal portion 32 of the positioner 30 or it may be a differentmaterial including but not limited to plastics, polymers, alloys, metalsor a combination thereof, that provide sufficient maneuverability andstiffness to the positioner 30 as necessary and desired. The positioner30 may extend from a location just distal of the stent-graft retentionregion 16 coaxial with a length of the inner cannula 22, through themain handle 10, and terminate at a distal end 34 within a stationarycollar 36 within the main handle 10. The stationary collar 36 withinwhich the distal end 34 of the positioner 30 is retained may include aninsert 38 which is secured to the positioner 30 to help retain thepositioner 30 within the stationary collar 36 (see the enlarged view ofthe distal end of the handle assembly 8 shown in FIG. 19 and FIG. 30).It can also be seen in FIG. 19 that a seal 40, such as an “0” ring orsilicone disc may be located adjacent to or just distal of the distalend 34 of the positioner 30 to maintain hemostasis within the mainhandle 10 and to prevent leakage or back flow of fluids though thepositioner 30. For a length of the positioner 30, a stiffening rod (notshown) may be disposed over the inner cannula 22 and/or over thepositioner 30 for additional stability and maneuverability.

Referring now to FIG. 3, an exemplary stent graft 42 is shown, which maybe deployed in a controlled and sequential manner using the deliverydevice 2 described herein. The stent graft 42 is carried on the innercannula 22 at the stent-graft retention region 16 as shown in FIGS. 4and 5. The stent-graft 42 has a proximal end 44 (that end with the barestent 46 extending therefrom), a distal end 48, and a series of stents50 extending the length of the stent-graft 42 and attached to the graftmaterial 52. Extending from the proximal end 44 of the stent-graft 42 isan exposed anchoring stent 46. Anchoring stent 46 is attached to thegraft material 52 by, for example, suturing the distal apices 54 of theanchoring stent 46 to the graft material. Anchoring stent 46 may haveone or more barbs 64 for attaching the stent-graft 42 to a body vessel.Barbs 64 may be at or near the proximal apices 66 of the anchoring stent46 and/or be located at some midpoint along the anchoring stent 46. Oneor more of the proximal apices 66 may include an opening or apertureformed therein, or as shown in FIGS. 3, 4 and 5, a suture loop or“lollipop” 74 may extend proximally from one or more of the proximalapices. The suture loops 74 are described in further detail below withreference to FIGS. 4 and 5. Radiopaque markers 68 may be placed onvarious parts of the device, including the proximal end 44, along one orboth limbs 58, 60, at the bifurcation 70, or other places.

Next adjacent the anchoring stent 46 is sealing stent 56. Sealing stent56 may be internal or external to the graft material 52. A series ofbody stents 50 also are attached to the graft material 52 and may besutured to the graft material or held to the graft material in otherknown ways. The series of body stents 50 may be internal or external tothe graft material 52, or both. As shown in FIG. 3, sealing stent 56 isinternal and body stents 50 are external to the graft material 52.

As shown in FIG. 3, stent-graft 42 is bifurcated having two limbs 58, 60extending from the tubular main body 62. One of the limbs 58 may beshorter than the other limb 60, or both may be the same length. Asdescribed herein, the shorter limb 58 may be referred to as the“contralateral limb” or “contralateral leg” while the longer limb 60 maybe referred to as the “ipsilateral limb” or “ipsilateral leg.” Limbs 58and 60 may also have a series of stents 72 along their length, either orboth internal and external. Although FIG. 3 shows a bifurcatedstent-graft 42, the stent-graft also may be a single non-bifurcated tubeas shown in FIGS. 4 and 5 and/or the stent graft may have one or morefenestrations formed in the graft material 52 and/or one or more sidebranches or arms or leg extension stent grafts extending therefrom. Inone non-limiting example, FIG. 25 shows a leg extension graft 258extending from the contralateral leg 58).

An exemplary coupling of the stent graft 42 to the delivery device isshown in FIGS. 4-6. More specifically, FIGS. 4-6 illustrate a proximalend portion 4 of the delivery device 2, and one non-limiting example ofan attachment and release mechanism for the proximal end 44 of a stentgraft 42 that can be operated using the handle assembly 8 describedherein. FIG. 4 shows the tapered nose cone dilator 18 having a proximaltip 20 and a reverse distal taper 78 at its distal end 82. The surfaceof the nose cone 18 presents a smooth tapered surface 76 to facilitateentry into and movement through a body vessel. Nose cone dilator 18 mayinclude radiopaque material or be equipped with a radiopaque marker (notshown) to facilitate visualization of the nose cone dilator 18 in use.

As shown in FIG. 6, an exemplary prosthesis attachment and retentionmechanism 80 (sometimes referred to herein as a “coiled member” or“coil” or “helix”) is disposed at or near the distal end 82 of the nosecone 18 and on the inner cannula 22. In a non-limiting example, as shownin enlarged view in FIG. 7, the attachment and release mechanism 80comprises a coiled member or helix 84 having a proximal end 86, a distalend 88, and a plurality of turns 90 disposed there between. However,other attachment and release mechanisms may also be used to releasablyattach the proximal end of the stent graft to the delivery deviceincluding one or more trigger wires, diameter reducing ties and the likeas will be recognized by one of skill in the art.

In one non-limiting example, the proximal end 86 of the coiled member 84is secured to the outer surface 92 of the cannula 22 using a suitableattachment mechanism 94, such as a solder, weld, mechanical attachment,friction fit, crimp, or combination of these or other techniques.Accordingly, the proximal end 86 of the coiled member 84 cannot moverelative to the outer surface 92 of the inner cannula 22. The proximalend 86 of the coiled member 84 comprises a first diameter d 1, which maybe approximately the same diameter, or slightly greater than, an outerdiameter of the cannula 22.

The distal end 88 of the coiled member 84 is unsecured relative to theouter surface 92 of the inner cannula 22, as shown in FIG. 7. The distalend 88 of the coiled member 84 may comprise a second diameter d 2 whichis greater than the first diameter d 1 of the proximal end 86 of thecoiled member 84. There is a separation or gap 96 between the distal end88 of the coiled member 84 and the outer surface 92 of the cannula 22,as best seen in FIG. 7.

The plurality of turns 90 are divided into a proximal series of turns98, which have the first diameter d 1, and a distal series of turns 100,which have the second diameter d 2. The proximal series of turns 98 maybe disposed in close proximity or abutting one another, as depicted inFIG. 7. By contrast, the distal series of turns 100 may be spaced apartfrom one another a greater distance than the proximal series of turns98. In FIG. 7, the distal series of turns 100 are spaced apart apredetermined distance denoted by spacing 102.

As shown in FIGS. 4 and 5, a prosthesis, such as stent graft 42, isdisposed on the inner cannula 22 at the proximal end 4 of the deliverydevice 2 at stent graft retention region 16. The stent graft 42 has anuncoupled state in which the graft is positioned coaxially over theinner cannula 22 with the proximal end 44 of the stent graft 42 inlongitudinal proximity relative to the distal end 88 of the coiledmember 84, as shown in FIG. 5. During assembly, one or more proximalapices 66 and/or one or more apertures or loops 74 that are coupled tothe proximal apices 66 of the stent 46 are threaded around the distalend 88 of the coiled member 84 one at a time, preferably until all ofthe proximal apices 66 and/or loops 74 are coupled to the coiled member84. Such coupling may be achieved by rotating the inner cannula 22 untilthe proximal end of the stent 46 is sufficiently compressed in aradially inward direction, as depicted in FIG. 4. A gap 96 between thedistal end 88 of the coiled member 84 and the outer surface 92 of theinner cannula 22 permits positioning of the proximal apices 66 or loops74 in the series of turns at the distal end 88 of the coiled member 84.This type of attachment system of the proximal stent to the deliverysystem is more fully described in U.S. application Ser. No. 13/796,395(filed Mar. 12, 2013) which is incorporated by reference in itsentirety.

The loops 74 (or apices) are further accommodated within a spacing 102between the distal series of turns 100. The loops 74 preferably arecoupled to the coiled member 84 in a manner in which at least one sutureloop 74 (or apex 66) is positioned around at least one full turn of thedistal series of turns 100, and preferably around at least 1.5 turns atthe distal end 88 of the coiled member 84, thereby reducing thelikelihood of inadvertent uncoupling of the loops 74 from the coiledmember 84.

The coupling shown in FIG. 4 secures the stent 46 to the cannula 22 viathe coiled member 84 in a manner that may subsequently facilitateinsertion of the subassembly comprising the inner cannula 22 and thestent graft 42 into an outer sheath 104, such as sheath 104 describedbelow. As will be apparent, the outer sheath 104 is configured toradially restrain other regions of the stent graft 42 for delivery to atarget site within a patient's anatomy.

The loops 74 may be coupled to every other proximal stent apex 66 asshown in FIG. 5 to restrain the stent 46 during delivery. In such acase, the loops 74 are not coupled to every other proximal apex 66,which may instead comprise barbs 64. By restraining the alternatingproximal apices 66 using the loops 74 coupled to the coiled member 84,the adjacent second proximal apices 66 also may be indirectly pulled ina radially inward direction during delivery. The configuration of thestent 46 facilitates the indirect compression of the adjacent secondproximal apices 66. Since only selected ones of the proximal apices 66are restrained during delivery, the number of apertures or loops 74 maybe reduced. This type of attachment system of the proximal stent to thedelivery system is more fully described with reference to FIGS. 4 and 5of U.S. application Ser. No. 13/796,395 (filed Mar. 12, 2013) whichdescription and Figures are hereby incorporated by reference in theirentirety.

As shown in FIG. 1, a longitudinally slideable and retractable 104extends along the length of the delivery device 2 from the main handle10 to the nose cone dilator 18. The sheath 104 is configured to coverand assist in retaining a prosthesis, such as a stent or stent graft 42,in a radially inwardly compressed, low-profile configuration duringdelivery of the prosthesis to a target site within a patient's anatomy.The distal end 106 of the sheath 104 is connected within the main handle10 by a sheath connector 108, which is shown in detail in FIG. 8. In oneexample, the distal end 106 of the sheath 104 may be slightly flared tofacilitate attachment of the sheath 104 to a correspondingly shapedtapered proximal end 110 of the sheath connector 108. The distal end 106of the sheath 104 may be secured to the proximal end 110 of the sheathconnector 108 by a friction fit, threaded engagement, adhesives or otherattachment mechanisms or combination thereof. The sheath connector 108has at least one lumen 112 extending from its proximal end 110 to itsdistal end 114, which allows for sheath connector 108 to travel or slidelongitudinally along the positioner 30. The sheath connector 108 alsoincludes a sheath flush port 116, comprising a one way valve thatcommunicates with the sheath connector lumen 112 to allow sheathflushing prior to introduction into the vasculature. An O-ring orsilicone disc at the distal end of the sheath connector lumen 112 and aseal within the sheath flush port 116 prevents unintended back flow orleakage of fluid through the sheath connector 108 and flush port 116.

Handle Assembly

FIG. 1 shows a rear perspective view of the delivery device 2 with thehandle assembly 8 while FIG. 2 illustrates a side cross-sectional viewof the of the handle assembly 8. As shown, the handle assembly 8includes a first or main handle 10 and second or outer handle 12. Themain handle 10 is fixed relative to the delivery device 2. The secondhandle 12 is disposed on at least a portion of the main handle 10 and ismovable longitudinally and/or circumferentially relative to the mainhandle 10.

The main handle 10 comprises a proximal end 118 and a distal end 120with an outer surface or side wall extending there between to form ahandle interior 124. As will be described below, the handle interior 124houses additional mechanical components that make up the handle assembly8. The main handle 10 may be injection molded as a single unitarystructure or alternatively, as shown in FIG. 9 the main handle 10 maycomprise upper and lower parts or first and second halves that clamshell, lock, snap-fit or are otherwise securable to each other.

The proximal end 118 of the main handle 10 may include a grippingportion 126 for a physician to grip with one hand while manipulating thesecond handle 12 (such as during sheath retraction during deployment).The gripping portion 126 of the main handle 10 is preferablyergonomically shaped for user comfort, and may be covered in a layer ofsofter plastic or rubber or have a gripping surface to ensure a stablegrip. As shown in FIG. 1, the gripping portion 126 is a proximal portion128 of the main handle that may have a greater diameter than theremainder of the main handle 10 which has a reduced diameter portion 130and extends distally behind the gripping portion 126. It is the reduceddiameter portion 130 of the main handle 10 upon which the second handle12 can longitudinally move.

At least a portion of the outer surface 122 of the main handle 10includes partial or full threads 132 along its surface 122, whichthreads 132 extend distally from a location just distal of the grippingportion 126 to the handle end cap 14. A longitudinal slot 134 having aproximal end 136 and a distal end 138 is formed along a portion of thelength of the main handle 10, between the gripping portion 126 and thehandle end cap 14. As shown in FIG. 1, the second handle 12 is locatedon the main handle 10. The second handle 12 may be a generally tubularstructure that extends at least partially around the outer surface 122of the main handle 10. The second handle 12 may be injection molded as asingle unitary structure or alternatively, as shown in FIG. 10 thesecond handle 12 may comprise upper and lower parts or halves that clamshell, lock, snap-fit by snaps 141 or are otherwise securable to eachother. The second handle 12 may further include an end cap 148. The endcap may 148 consist of two halves which can be attached together byvarious mechanisms such as snap fit, friction fit, correspondingengageable protrusions or by adhesives. The second handle 12mechanically engages with the end cap 148 thereby preventingaxial/longitudinal movement between the respective two parts but allowsthe second handle 12 to rotate independently from the end cap 148. Inone example, as shown in FIG. 10, one or more protrusions 160, such as acollar, thread or ring on the inner surface 140 of the second handle 12may be engageable with a correspondingly shaped collar, protrusion,thread or ring on the end cap 148.

The inner surface 140 of the second handle 12 may further comprise oneor more structures, which engage with a mechanism such as a nut 142. Aspreviously mentioned, the nut 142 is located within the second handle12. In one non-limiting example, as shown in FIG. 10, the second handle12 may comprise an opening or aperture 144 which engages with one ormore radial protrusions 146 on the nut 142 (See FIGS. 28B, 29B and 31).As such, at least a portion of the inner surface 140 of the secondhandle 12 is engaged or otherwise operatively connected with the nut142. One of skill in the art would recognize that any similar mechanismsor structures that allow the second handle 12 to engage with the nut 142may be used. As shown in FIG. 11 and FIG. 11A, the nut 142 may be acylindrical or tubular structure that completely encircles a portion ofthe main handle 10, or the nut 142 may partially cover or surround themain handle 10. In one example, the nut 142 may be a solid structure, oras shown in FIGS. 11A, 31 and 32, a distal end 149 may be a solidstructure or ring which encircles a portion of the main handle 10 whilea proximal end 150 of the nut 142 may comprise a series of adjacentpanels, fingers or flanges that extend proximally from the distal end149 of the nut 142. The nut 142 may be constructed from a resilientmaterial, including plastics, rubbers, metals, polymers, metals or acombination thereof. As shown in FIG. 11A, the nut is constructed of aresilient material and includes one or more shimstocks 151 that areintegrally formed with the nut or alternatively, the shimstocks 151 areseparate components that are fitted within a correspondingly shapedchannel formed in the nut and then secured to the nut, such as byadhesives or other acceptable attachment mechanisms. The shimstocks 151are essentially a thin stainless steel flat wire with thickness of about0.003-0.010″ may serve as a “skeleton” to the nut. As will be describedin further detail below, the proximal end 150 of the nut 142, includingthe series of fingers or flanges, may flare radially outwardly in aneutral or relaxed state. (See FIG. 11A and FIG. 32, for example). Theproximal end of the nut has a second radially inwardly compressed state,such that the inner surface of the nut 142 is configured to engage withan outer surface 122 of the main handle 10. (See FIG. 31, for example.)The shimstocks 151 help to preserve the shape of the nut and maintainthe resiliency of the nut, to help ensure that the proximal end of thenut can move from the inwardly compressed state to the radiallyoutwardly flared state. In one non-limiting example, the shimstocks 151help to safeguard from the effect of ageing of plastic or otherresilient materials from which the nut 142 may be constructed bypreserving resiliency and the tendency for the nut 142 to flare radiallyoutwardly. If the nut loses its elasticity or resiliency, the internalthreads on the nut 142 may not fully separate or disengage from theexternal threads 132 of main handle 10 when the sheath 104 is retracted.The shimstocks 151 facilitate disengagement of the nut 142 from the mainhandle 10 when necessary or desired as described in detail below.

The second handle 12 may be rotated to move it from its first proximalmost position on the main handle 10 (as shown in FIGS. 1 and 14) tovarious intermediate positions (FIGS. 16, 23, 26, and FIGS. 28A and 28B,for example) located between the proximal and distal ends 136, 138 ofthe longitudinal slot 134 formed in the main handle 10. Distal movementof the second handle 12 relative to the main handle 10 requires rotationof the second handle 12 when the inner surface 152 of the nut 142 withinthe second handle 12 is threadedly engaged with the outer surface 122 ofthe main handle 10. In other words, this threaded engagementnecessitates rotation of the second handle 12 to impart longitudinalmovement of the second handle 12 relative to the main handle 10.Rotation of the second handle 12 may be desired so as to provide morecontrol and accuracy to the sheath retraction and proximal stent 46placement and deployment (as shown in FIGS. 15 and 25, for example).

FIGS. 11 and 12 are perspective views of the handle assembly 8 shownwith a portion of the second handle 12 removed, showing the secondhandle 12 in a proximal most position on the main handle 10. A ratchetedcollar 154 is positioned under the second handle 12. The ratchetedcollar 154 may fully or partially surround the main handle 10. As shownin FIG. 11, the ratcheted collar 154 extends distally from the grippingportion 126 of the main handle 10. The ratcheted collar 154 may bemolded from a single unitary piece of material or may be multipleseparately-molded pieces (i.e., a collar portion 154 a and a ratchetportion 154 b) which are attached together such as by welding or glue.The ratcheted collar 154 may have one or more protrusions or teeth 156that allow only for unidirectional rotation of the second handle 12. Forexample, one or more protrusions 158 formed on the inner surface 140 ofthe second handle 12, or, alternatively a shim 158 positioned in a sloton the interior surface 140 of the second handle 12, as shown in FIG.10, engage with the ratcheted collar 154, so that the second handle 12can rotate about the main handle 10 in one direction, while rotation ofthe second handle 12 about the main handle 10 in the opposite directionis prevented. The ratcheted collar 154 is preferably shaped so that theratcheted collar 154 does not rotate relative to the main handle 10, butwhich allows the ratcheted collar 154 to slide longitudinally relativeto the main handle 10. For example, the cross-sectional shape of theratcheted collar 154 may be oblong or polygonal, have one or more flatsides or be irregularly shaped so that rotation of ratcheted collar 154is prevented when the second handle 12 is rotated about the main handle10, but which allows the ratcheted collar 154 to move longitudinallyalong the main handle 10 as the second handle 12 is moved distally bythe user.

Before use of the delivery device 2 and when the delivery device istracked to a desired location within a patient's body, the second handle12 is disposed in a first or proximal most position on the main handle10 and the stent graft 42 at the proximal end 4 of the delivery device 2is fully sheathed and held in a radially inwardly contracted conditionas shown in FIGS. 1, 13, 13A and 14 and 43. More specifically, with thestent graft 42 fully sheathed, the series of stents 50 on the main bodyof the stent 62 as well as the leg stents 72 are held in a radiallyinwardly contracted condition as shown in FIG. 13A, which is an enlargedview of a portion of the sheathed stent graft 42 in FIG. 13. As thesecond handle 12 is rotated to move it distally along the main handle10, the protrusion 160 (such as a collar or ring on the inner surface140 of the second handle 12) engages with a protrusion on the end cap148 as shown in FIG. 10. As mentioned above, the second handle 12 canrotate freely and independently of the end cap 148. As the second handle12 rotates and moves distally along the main handle 10, the end cap 148is pushed distally, which in turn pushes the sheath connector 108distally, thereby also pulling the sheath 104 distally, to expose aproximal end 44 of the stent graft 42, such as the top stent 46 and sealstent 56 portions of the stent graft as shown in FIG. 15. Retracting thesheath 108 to expose a proximal end 44 of the stent graft 42, such asthe top and seal stent 42, 56 may sometimes be referred to “exposing thediamond” by one of skill in the art. The longitudinal slot 134 formed inthe main handle 10 accommodates the sheath flush port 116 on the sheathconnector 108, such that as the second handle 12 is moved distallyrelative to the main handle 10, the sheath flush port 116 can slidedistally along with the sheath connector 108 and the second handle 12through this longitudinal slot 134 formed in the main handle 10.

By moving the second handle 12 distally relative to the main handle 10,a prosthesis release actuation mechanism 162, sometimes referred toherein as a “proximal suture drum 162” also becomes exposed and is nowvisible and accessible by the user as shown in FIG. 16. The proximalsuture drum 162 is disposed about the main handle 10, just distal to thegripping portion 126 of the main handle 10 and just proximal to the nut142. The proximal suture drum 162 is rotatable about the main handle 10.In other words, when the second handle 12 is disposed in a first orproximal most position on the main handle 10 as shown in FIGS. 12 and14, the second handle 12 covers the proximal suture drum 162 so that theproximal suture drum 162 is not visible and cannot be accessed and/ormanipulated (rotated) by the user. FIGS. 11 and 12 illustrate the secondhandle in a proximal most position on the main handle with a portion ofthe second handle 12 cut away to see the location of the proximal suturedrum 162 hidden under the second handle 12. The proximal suture drum 162may have one or more longitudinal grooves 164 on its outer surface (seeFIGS. 12 and 18), which engage with one or more correspondingly shapedprotrusions on the inner surface 140 of the second handle 12 to preventpremature or unintended rotation of the proximal suture drum 162 untilthe second handle 12 has been properly and sufficiently moved in adistal direction to expose the proximal suture drum 162. In other words,access to and rotation of the proximal suture drum 162 is prevented bythe second handle 12 until an appropriate stage of a deployment sequence(i.e., after the second handle 12 has been retracted distally therebywithdrawing the sheath 104 a sufficient distance to expose at least theproximal end of the stent graft and deployment of the top stent 46 isappropriate and desired as described below). However, when the secondhandle is in the proximal most position on the main handle 10 as shownin FIG. 14, the prosthesis, such as a stent-graft 42 disposed on thedelivery device 2 at a stent-graft retention region 16 is fully coveredby the retractable sheath as shown in FIGS. 1 and 13 and 43.

As shown in FIG. 9, the main handle 10 may further comprise one or moreradial protrusion(s) 168, such as a tooth or post. This protrusion 168may be located just distal of the gripping portion 126 and is configuredto engage with a ratchet 170 within the proximal suture drum 162 asshown in FIG. 17. In one example, the ratchet 170 within the proximalsuture drum 162 may be integrally formed with at least a portion of aninternal surface 172 of the proximal suture drum 162, or alternatively,the ratchet 170 may be a separate component that is connected or securedto the interior 172 of the proximal suture drum 162. Alternatively, inplace of or in combination with the ratchet 170, a thin metal shiminserted within a radial slot formed in the wall of the inner surface172 of the proximal suture drum 162 may serve as the ratchet thatengages with the radial protrusion 168 extending from the outer surface122 of the main handle 10.

Preferably, the ratchet 170 present on the inside 172 of the proximalsuture drum 162 allows only for unidirectional rotation of the proximalsuture drum 162. In other words, the ratchet 170 permits rotation of theproximal suture drum 162 in one particular direction, but preventsrotation of the proximal suture drum 162 in the opposite direction. Forexample, the ratchet 170 may be configured so that it engages with theradial protrusion 168 on the main handle 10 to prevent counter-clockwiserotation of the proximal suture drum 162, but permits clockwise rotationof the proximal suture drum 162. It will be appreciated that thecomponents of the handle assembly 8, including the proximal suture drum162, may be designed to rotate in any particular direction, however, asdescribed herein for exemplary purposes, the ratchet 170 is configuredto permit clockwise rotation of the proximal suture drum 162 and preventcounter-clockwise rotation.

As depicted generally in FIGS. 16, 18 and 19, a motion translatingmechanism 174, sometimes referred to herein as a “distal suture drum174,” is disposed distal to the proximal suture drum 162 and is locatedwithin an end cap 14 at the distal end 120 of the main handle 10. Theback end cap 14 may be a single structure or multiple parts or halvessnap-fitted together and into engagement with the distal end 120 of themain handle 10. End cap 14 may have a distal taper 176 and may beremovable or split open by the user should the need arise, such as in anemergency “bailout” procedure in the event that one or more componentsof the handle assembly 8 fail during deployment, thus allowing the userto remove the end cap 14 and access the handle interior 124, includingthe distal suture drum 174, to manually perform certain deployment stepsdescribed in further detail below. The inner cannula 22 extends distallythrough the back end cap 14 to the distal flush hub 24, as can be seenin FIG. 19.

With reference to FIG. 18, the distal suture drum 174 is operativelyconnected with the proximal suture drum 162. The distal suture drum 174is disposed circumferentially around and connected to the inner cannula22, such as by the pin vise 178, although other suitable mechanisms forattaching the inner cannula 22 to the distal suture drum 174 are alsocontemplated, including adhesives, for example. As will be discussed ingreater detail below, the distal suture drum 174 is configured to rotatethe inner cannula 22 to effect the release of the prosthesis 42 from theprosthesis retention mechanism 80.

In one non-limiting example, the proximal suture drum 162 (e.g. theprosthesis release actuation mechanism) is operatively connected to thedistal suture drum 174 (e.g., the motion translating mechanism) by anelongated filamentous material 180, such as a suture, string, wire,cord, thread and the like. The suture 180 may be composed of ultra-highmolecular weight polyethylene (UHMWPE); alternatively, a nitinol wire orother suitable materials may be utilized. The suture 180 serves totransfer motion of the proximal suture drum 162 to the distal suturedrum 174. In one example, as shown in FIGS. 20 and 21, the suture 180 ispre-wound around the distal suture drum 174 at a suture-wrapping portion182 a select number of times and secured to the distal drum 174, such asvia a set screw 184 and/or a 4-40 screw thread. The suture 180 thenextends from where it is wrapped around the suture wrapping portion 182of the distal suture drum 174 over/around a pin 186 extending generallyperpendicularly to the longitudinal axis of the main handle 10. In oneexample, each end of the pin 186 is held within an opening or slot 188formed in the distal end 120 of the main handle 10. After wrapping upand over the pin 186, the suture 180 extends longitudinally forward orproximally through a small suture cannula 190 that is embedded in asidewall of the main handle 10 or which extends longitudinally throughthe main handle 10 generally parallel to an inner surface 124 of themain handle 10. The suture 180 then exits the suture cannula 190 at aproximal location 192 on the main handle 10 adjacent to where theproximal suture drum 162 sits on the main handle 10, as shown in FIG.22. The suture 180 exits the suture cannula 190 and is connected to theproximal suture drum 162. In one example, as FIG. 17 shows, the innersurface 172 of the proximal suture drum 162 has an attachment surface,such as a “J” peg and/or post 194 around which the suture 180 may bewrapped one or more times and then secured to the proximal suture drum162 by a set screw 196. It is also contemplated that the suture 180 canbe secured to the proximal suture drum 162 by other suitable attachmentmechanisms, such as being threaded through an opening or aperture, tied,crimped and/or secured by adhesives or a combination thereof.

When the proximal suture drum 162 is rotated (such as in a clockwisedirection as indicated in FIG. 26) the suture 180 connected to the innersurface 172 of the proximal suture drum 162 starts to wind around aproximal portion 198 of the outer surface 122 of the main handle 10 asshown in FIGS. 9 and 22 (where the proximal suture drum 162 has beenremoved to show the detail and location of the suture 180 wrappingaround proximal portion 198 of the main handle 10). The proximal portion198 of the main handle 10 on which the suture 180 is wound may be smoothor bare, or alternatively, it may be threaded so that the suture 180 iswound in parallel loops so there is no overlap. Rotation of the proximalsuture drum 162 by the user winds the suture 180 around the outersurface 122 of the main handle 10, and simultaneously, the suture 180unwinds from the distal suture drum 174. In other words, as the proximalend of the suture 180 winds around proximal portion 198 of the mainhandle 10, the distal end of the suture 180 unwinds from the distalsuture drum 174, thus causing the distal suture drum 174 to rotate. Asthe distal suture drum 174 rotates, the inner cannula 22 rotates alongwith it. Because the inner cannula 22 extends substantially the entirelongitudinal length of the delivery device 2, the rotation of the distalsuture drum 174 at the distal end 120 of the handle assembly 8 causesthe inner cannula 22 to rotate along its entire length. Rotation of theinner cannula 22 along its entire length effects release of theprosthesis retention mechanism 80 from the proximal end 44 of the stentgraft 42 as will be described below.

As shown in FIG. 22, the diameter 200 of the proximal suture wrappingportion 198 of the main handle on which the proximal drum 162 sits (andupon which the suture 180 becomes wrapped during use) may determine thediameter 202 (FIG. 21) of the distal suture wrapping portion 182 of thedistal suture drum 174 upon which the suture 180 is wrapped. Forexample, it may be preferable that a user grips and/or re-grips arotating part, such as the proximal suture drum, three times to enableone complete 360 degree rotation of the proximal suture drum 162. Thus,it may be desirable for the user to rotate the proximal suture drum 162one or 1.5 times to effect release of a proximal end (i.e., the topstent 46) of the prosthesis 42. At the same time, in order for theproximal stent apices 66 (and/or apertures or loops 74 on the top stent46) to be uncoupled from the coiled member 84 on the inner cannula 22,the cannula 22 needs to rotate approximately 3-4 times (3-4 completerevolutions if considering tortuous anatomy) to safely release the topstent 46. In other words, one complete rotation of the proximal suturedrum 162 preferably causes 3-4 rotations of the distal suture drum 174,which may be accomplished by making the distal suture drum diameter 202upon which the suture 180 wraps approximately 3-4 times smaller than thediameter 200 of the proximal suture wrapping portion 198. This may becalculated using the following exemplary equation:

${{\phi \left( {{Diameter}\mspace{14mu} {of}\mspace{14mu} {distal}\mspace{14mu} {suture}\mspace{14mu} {drum}\mspace{14mu} {upon}\mspace{14mu} {which}\mspace{14mu} {the}\mspace{14mu} {suture}\mspace{14mu} {is}\mspace{14mu} {wrapped}} \right)} = \frac{\phi\left( \mspace{14mu} \begin{matrix}{{Diameter}\mspace{14mu} {of}\mspace{14mu} {outer}\mspace{14mu} {surface}\mspace{14mu} {of}} \\{{main}\mspace{14mu} {handle}\mspace{14mu} {upon}\mspace{14mu} {which}\mspace{14mu} {the}\mspace{14mu} {suture}\mspace{14mu} {wraps}}\end{matrix} \right)}{n}}{where}n = {{number}\mspace{14mu} {of}\mspace{14mu} {rotations}\mspace{14mu} {of}\mspace{14mu} {the}{\mspace{11mu} \;}{inner}\mspace{14mu} {cannula}\mspace{14mu} {required}{\mspace{11mu} \;}{to}\mspace{14mu} {deploy}\mspace{14mu} {the}\mspace{14mu} {top}\mspace{14mu} {{stent}.}}$

Thus, in one non limiting example, n=3 or 4 rotations of the innercannula.

It should be understood that this configuration of the present inventionis not limiting and that one skilled in the art would appreciate thatdifferent diameters of the proximal and distal suture drums 162, 174 canbe used to achieve a desired number of rotations of the inner cannula 22to effect the release of a prosthesis 42.

With the sheath 104 retracted to expose the top stent 46 and/or sealstents 56 at the proximal end 44 of the stent graft 42 and the proximalsuture drum 162 visible and accessible, as shown in FIGS. 15 and 16, theuser may continue to rotate the second handle 12 to further move thesecond handle 12 distally along the main handle 10, thus furtherretracting the sheath 104 and exposing the main body 62 of the stentgraft 42 (and, depending on the length of the contralateral limb 58,also expose at least a portion of the contralateral limb 58 as shown inFIG. 23 and FIG. 24). In cases where the contralateral limb 58 isrelatively short, the second handle 12 may only need to be moveddistally on the main handle 10 to a position such as that shown in FIG.23 and the contralateral limb 58 may be fully exposed. On the otherhand, in cases where the contralateral limb 58 is relatively longer, thesecond handle 12 must be moved distally on the main handle 10 as farback as the distal trigger wire knob 204 in order to fully un-sheath andexpose the contralateral limb 58 as shown in FIG. 26.

The second handle 12 may continue to move distally until the distal end14 of the sheath connector 108 within the second handle 12 and/or theend cap 148 touches, meets, abuts or is otherwise adjacent to a distaltrigger wire knob 204 located within the main handle interior 124, asshown in FIGS. 26, and 28A and 28B. The user may feel a slightresistance which signals that the sheath connector 108 has reached thedistal trigger wire knob 204. Other visual or mechanical signals mayalso be present on the delivery device 2 and/or handle assembly 8 toindicate to the user to stop rotating the second handle 12 (to therebystop further distal movement of the second handle 12 along the mainhandle 10) including visual cues provided by desired imaging modality(i.e., by fluoroscopy, MRI, 3D or other imaging techniques). At thispoint, distal movement of the second handle 12 relative to the mainhandle 10 has moved the sheath connector 108 distally, therebyretracting the sheath 104 a sufficient travel distance 206 such that thetop stent 46, stent-graft main body 62 and at least a portion of thecontralateral limb 58 has been exposed. The ipsilateral limb 60,however, is still sheathed, as shown in FIG. 24.

At this stage, the top stent 46 may be released as shown in FIG. 25 byrotating the proximal suture drum 162 as shown in FIG. 26. As previouslymentioned, release of the top stent 46 may be accomplished by clockwiserotation of the proximal suture drum 162. Rotation of the proximalsuture drum 162, which is operatively connected to the distal suturedrum 174 via the suture 180, thereby effects rotation of the innercannula 22 (including the prosthesis retention mechanism 80 at theproximal end of the cannula 22) to enable release of the top stentapices 66 or loops 74 captured by the coil or helix 84, as shown inFIGS. 4 and 5.

As previously mentioned, the components of the handle assembly 8,including the proximal suture drum 162, distal suture drum 174 and/orinner cannula 22 (including the prosthesis retention mechanism 80 orcoiled member 84) may be designed, manufactured and assembled to rotatein any particular direction (clockwise and/or counterclockwise). Anyparticular direction as described and designated herein is for exemplarypurposes only and should not be considered so limiting. In one example,the proximal suture drum 162 may be rotated clockwise, but the directionthat the distal suture drum 174 rotates may depend on how the suture 180is pre-wound on the distal suture drum 174 (either clockwise wound orcounter-clockwise wound). Thus, rotation of the proximal suture drum 162(i.e., the prosthesis release actuation mechanism) in a first directioneffects rotation of the distal suture drum 174 (i.e., the motiontranslating mechanism) in a second direction and wherein rotation of thedistal suture drum 174 (i.e., the motion translating mechanism) effectsrotation of the inner cannula 22 and the coiled member 84 (i.e., theprosthesis retention mechanism 80) in a third direction. The first,second and third directions may be the same, or the first, second andthird directions may be different, or a combination thereof. In anon-limiting example, the proximal suture drum 162 may be rotatedclockwise by the user, and the suture pre-wrapped upon the distal suturedrum 174 in a clockwise direction, which, when unwound from the distalsuture drum 174, rotates the distal suture drum 174 in a clockwisedirection thereby rotating the inner cannula 22 in a clockwisedirection. Alternatively, the proximal suture drum 162 may be designedand assembled for counter-clockwise rotation, as can the distal suturedrum 174 and/or inner cannula 22.

After the top or proximal stent 46 has been released, the second handle12 can then be moved further distally relative to the main handle 10(from the position shown in FIGS. 23, 26 and 28A and 28B) to a final ordistal most position on the main handle 10 (as shown in FIGS. 29A and B)to further retract the sheath 104 while simultaneously withdrawing oneor more distal trigger wires to thereby deploy the ipsilateral limb 60of the stent graft 42 as shown in FIG. 27. This final distal movement ofthe second handle 12 to a position on the main handle 10 as shown inFIGS. 29 A and B may be accomplished by the user continuing to rotatethe second handle 12 relative to the main handle 10 as described above,where rotation of the second handle 12 causes the second handle 12 totravel distally in a longitudinal direction along the main handle 10.Alternatively, rather than continuing to rotate the second handle 12 tomove it distally, the user has the option to implement a “quick release”protocol in order to retract the second handle 12 distally withoutrotation, as will be described in further detail below.

The distance of travel of the second handle 12 relative to the mainhandle 10 to this final or distal most position is identified asreference number 210 in FIG. 29 A. In other words, distal movement ofthe second handle 12 from an intermediate position in FIGS. 28A and B tothe distal most position in FIGS. 29 A and B causes the sheath connector108 to retract distally (thereby retracting the sheath 104 distally) toexpose the ipsilateral limb 60 of the stent graft 42. At the same time,the distal end or end cap 148 of the second handle 12 and/or the distalend 114 of the sheath connector pushes against a distal trigger wirerelease mechanism 204 located within the main handle 10. As shown inFIG. 30, the distal trigger wire release mechanism 204 is a ring that isslidably disposed over the positioner 30. One or more distal triggerwire(s) 208 extend proximally from the distal trigger wire releasemechanism 204 to the distal end of the stent-graft 48 as describedfurther below and shown in FIG. 30 and FIGS. 39-42.

In one example, the positioner 30 provides a conduit for the distaltrigger wires 208 to extend from the trigger wire release mechanism 204in the main handle 10 to the distal end 48 of the stent graft 42. Asshown in FIG. 30, one or more trigger wires 208 may be secured to thedistal trigger wire release mechanism 204 by a set screw 214. Thetrigger wire 208 then extends from the trigger wire release mechanism204 and into an opening, hole or aperture 216 formed in the positioner30, where the distal trigger wire(s) 208 further extend proximallythrough the conduit provided by the positioner 30 to the distal end 48of the stent graft 42. A seal 218, such as a silicone sleeve or disc maybe provided to cover the hole 216 formed in the positioner 30 andprevent back-leakage of fluids through the hole 216.

The distal trigger wire(s) 208 may be directly or indirectly attached tothe distal end 48 of the stent graft 42. For example, the distal triggerwires 208 may engage a suture loop 209 which is attached to the distalend 48 of the ipsilateral limb 60 of the stent-graft 42 as shown inFIGS. 39 and 40. Alternatively, the distal trigger wire 208 may be wovendirectly through or removably attached to the graft material 52 or oneor more stents 72 at the distal end of the graft 42 as shown in FIGS. 41and 42. Other suitable attachment methods or mechanisms may be used toremovably attach the distal trigger wires 208 to the distal end of thestent graft 42 as would be recognized by one of skill in the art.

As FIGS. 29A and B illustrate, distal movement of the second handle 12pushes or drives the distal trigger wire knob 204 distally with it,thereby pulling the one or more distal trigger wires 208 in a distaldirection. The proximal end of the distal trigger wire(s) 208 arethereby withdrawn or become disengaged from the distal end of the stentgraft 42 (i.e., the distal trigger wires 208 become released from thesuture loop and/or become disengaged from the graft material 52 at thedistal end of the ipsilateral limb 60). Distal movement of the secondhandle 12 ceases upon second handle 12 reaching the distal end 138 ofthe longitudinal slot 134 formed in the main handle 10 and/or when thedistal trigger wire knob 204 abuts or contacts the stationary collar 36at the distal end 120 of the main handle 10.

The steps of a “quick release” procedure are now generally described. Asset forth above, second handle 12 can rotate about the longitudinal axisof the main handle 10 to move the second handle 12 distally, thusretracting the sheath 104 to expose the proximal stent 46, the main body62 and the contralateral limb 58 of the stent graft 42 as shown in FIG.24. The threaded engagement between the inner surface 152 of the nut 142and outer surface 122 of the main handle 10 necessitates rotation toimpart longitudinal movement of the second handle 12 relative to themain handle 10. The user may continue to rotate the second handle 12 tomove it distally to further retract the sheath 104 to expose theipsilateral limb 60 and release the trigger wires 208 from the distalend of the stent graft 42 during deployment. However, as an alternative,the “quick release” procedure may be employed at this stage ofdeployment, if desired, in order to further retract the sheath 104 toexpose the ipsilateral limb 60 and to release the distal trigger wires208 without having to rotate the second handle 12 relative to the mainhandle 10.

More specifically, instead of rotating the second handle 12 to move itdistally relative to the main handle 10, the “quick release” procedureprovides the user the ability to slide the second handle 12 freely alongthe main handle 10 in a straight pull-back motion, so that the secondhandle 12 can simply slide longitudinally along the main handle 10 in acontinuous smooth non-rotating motion. This provides several advantages,including, for example, the user being able to retract the second handle12 more quickly and without rotation to complete sheath retraction anddistal trigger wire removal. It also facilitates a final stage of adeployment procedure once the entire stent graft 42 is deployed,allowing the user to re-sheath or recapture at least a portion of thenose cone 18 within the sheath 104 for removal of the device 2 from apatient's body as will be described in further detail below.

In the first steps of the “quick release” procedure, the user can firmlygrip the gripping portion 126 of the main handle 10 with one hand whilepulling back on an outer handle or ring 220 located on the second handle12 with the other hand as FIG. 28 A shows to “release” or disengage thesecond handle 12 from the main handle 10, thus allowing the secondhandle 12 to slide freely along the main handle 10 without rotation in astraight pull-back motion.

More specifically, as shown in FIGS. 31 and 32, the nut 142 locatedwithin the second handle 12 extends at least partially circumferentiallyaround at least a portion of the main handle 10. As shown in one examplein FIG. 31, the inner surface of the nut 142 is engaged with threads 132on the outer surface 122 of the main handle 10 by a threaded engagement,although other mechanisms may be used to provide engagement between thenut 142 and the main handle 10. With the inner surface 152 of the nut142 engaged with the outer surface 122 of the main handle 10, the secondhandle 12 must be rotated in order to move the second handle 12 distallyalong the main handle 10 (such as during the previously-described stepsof moving the second handle 12 distally to facilitate sheath retractionand proximal stent deployment.)

As shown in FIGS. 31 and 32, a sleeve 222 extends at least partiallycircumferentially over and/or around the nut 142, or alternatively, thesleeve 222 may completely surround or enclose a portion of the outersurface of the nut 142. In one non-limiting example, the sleeve 222 maybe a curved, arcuate and/or semi-circular structure that is positionedabout the outer surface of the nut 142, as shown in FIG. 31 A. The outersurface of the sleeve 222 may have one or more radially outwardlyextending protrusions 224 that extend through one or more openings orslots 226 formed in the second handle 12 (see FIG. 10) so as to engagewith an opening or channel formed in the inner surface of the outerhandle or ring 220. Any other suitable mechanisms and/or correspondinglyshaped structures on the sleeve 222 that are configured to allow thesleeve 222 to connect to or operatively engage with the outer handle orring 220 may also be used as would be recognized by one of skill in theart.

When the ring 220 is in a first or proximal position relative to thesecond handle 12 as shown in FIG. 31, the sleeve 222, which isoperatively engaged with the outer handle or ring 220 as previouslydescribed, is also positioned at a proximal end 150 of the nut 142. Thesleeve 222 holds the proximal end 150 of the nut 142 in a radiallyinwardly compressed condition and prevents such outward flaring of thenut 142. Thus, the sleeve 222 maintains and/or urges the nut 142radially inwardly and the urges the threads on the inner surface 152 ofthe nut 142 into engagement with the outer surface 122 of the mainhandle 10. Thus, when the ring 220 is in this first or proximal positionon the second handle 12 (FIG. 31), the nut 142 is engaged with the mainhandle 10 such that the second handle 12 must be rotated to move thesecond handle 12 longitudinally in a distal direction.

However, during quick release, the ring 220 is moved from the firstproximal position to a second distal position (see FIG. 32) by the userto move the sleeve 222 distally relative to the nut 142. As shown inFIG. 32, when the sleeve 222 is moved distally, the proximal end 150 ofthe nut 142 is permitted to expand radially outwardly or flare so thatthe inner surface 152 of the nut 142 is released from engagement withthe main handle 10. In one example, the nut 142 is self-expanding, suchthat when the sleeve 222 is moved distally, the proximal end 150 of thenut 142 may expand radially outwardly without the aid or assistance ofmechanical expansion techniques because the proximal end 150 of the nut142 may have a tendency to flare radially outwardly in a natural orrelaxed position. Shimstocks 151 may, if present, help facilitate suchoutward flaring to ensure that the nut 142 disengages from the mainhandle 10. However, in another example, the nut 142 may also bemechanically expanded. In particular, as shown in FIG. 31A, the proximalportion 228 of the sleeve 222 includes an expanding structure 230 thatis configured to engage with at least a portion of the inner surface 152of the nut 142 and urge the proximal end 150 of the nut 142 radiallyoutwardly. Thus, as the sleeve 222 is moved distally, the expandingstructure 230 comes into contact with the proximal end 150 of the nut142 to radially outwardly expand the proximal end 150 of the nut 142.The inner surface 152 of the nut 142 thus becomes disengaged from themain handle 10 allowing the second handle 12 to be moved distally alongthe main handle 10 in a straight pull-back motion without rotation.

The expanding structure 230 may be in the form of a ring, partial ring,semi-circle, wedge and/or any other structure that facilitates radialexpansion of the nut 142. As shown in FIGS. 31, 31A and 32, theexpanding structure 230 is a semi-circular structure that is locatedjust proximal to and connected to the sleeve 222. The expandingstructure 230 has a radius that is smaller than the radius of the sleeve222. When the ring 220 is pulled distally back, the sleeve 222 with theexpanding structure 230 also moves distally back. The expandingstructure 230 drives itself between the outer surface 122 of the mainhandle 10 and the inner surface 152 of the proximal end 150 of the nut142, thus urging the proximal end 150 of the nut 142 in a radiallyoutwardly expanded condition. Thus, even if the nut 142 isself-expanding but somehow fails to self-expand upon movement of thering 220 (and simultaneously, the sleeve 222) to a distal position, thenthe expanding structure 230 will facilitate the radially outwardexpansion of the proximal end 150 of the nut 142 to disengage the nut142 from the main handle 10, allowing the quick release procedure tostill be utilized. A self-expanding nut 142 may fail to sufficientlyexpand or become deformed so that it cannot fully disengage from themain handle 10 because of age and/or sterilization, for example.Alternatively, if the nut 142 is not self-expanding and is dependent onmechanical expansion, the expanding structure 230 serves to facilitatethe radially outward expansion of the proximal end 150 of the nut 142during the quick release procedure.

The action of sliding outer ring 220 distally preferably also makesvisible an arrow (or set of arrows or other similar markings) on thesecond handle 12 as shown in FIGS. 28A and 29A, which serve as anindicator to the user that the second handle 12 is ready for “quickrelease” by straight distal pull-back of the second handle relative tothe main handle 10. At this time, with the proximal end 150 of the nut142 flared radially outwardly as shown in FIG. 32, the second handle 12is disengaged from the main handle 10 and can be slid distally towardsthe user in a straight pull-back motion (without rotation) so thatfurther retraction of the sheath 104 to expose the ipsilateral limb 60can be completed while simultaneously withdrawing the distal triggerwire(s) 208 to fully release the stent graft in the vasculature as shownin FIGS. 27 and 44, thus accomplishing a “quick release” portion of thedeployment procedure.

Another embodiment of the handle assembly 8 is shown in FIGS. 33-38,where like reference numbers identify like features as previouslydescribed, where appropriate. As shown in FIGS. 33-38, the handleassembly 8 further comprises a notched or threaded rack-like mechanism232 which engages with the proximal suture drum 234. In a non-limitingexample, the rack 232 has a proximal end 236 and a distal end 238, andhas threads 240 formed on at least a portion of the rack's outer surfaceextending between the proximal and distal ends 236, 238. The rack 232 islocated inside the main handle 10 near the proximal end of the mainhandle 10. A slot or channel 242 formed in the proximal end 118 of themain handle 10 allows the rack 232 to travel longitudinally in aproximal direction inside the main handle 10.

The proximal end of the suture 180 is secured to or otherwise connectedto the rack 232 as shown in FIGS. 35 and 36. For example, the suture 180may be secured to the distal end 238 of the rack 232 via a J post or setscrew 246, or alternatively or in combination, the suture 180 may bethreaded or tied around or through an aperture or slot 244 formed in thedistal end 238 of the rack 232 and/or secured to the rack with adhesivesor other suitable attachment mechanisms. The threads 240 on the outersurface of the rack 232 are engageable with threads 248 formed on theinner surface of a proximal suture drum 234, shown in FIG. 38.

When the proximal suture drum 234 is rotated, threads 240 on the innersurface of the proximal suture drum 234 engage with the threads 240 onthe rack 232, thus pulling or moving the rack 232 longitudinally in aproximal direction. As the rack 232 moves longitudinally in a proximaldirection, the rack 232 thereby pulls the suture 180 proximally alongwith it, thus pulling the suture 180 off the distal suture drum 174. Asthe suture 180 is pulled off the distal suture drum 174, the distalsuture drum 174 rotates, and in turn, rotates the inner cannula 22 alongits entire length. In the same manner as already described in detailabove, rotation of the inner cannula 22 causes the prosthesis retentionmechanism 80 to rotate, and thereby release the prosthesis 42 carried atthe proximal end 4 of the delivery device 2.

As shown in FIGS. 35 and 36, the rack 232 may further include one ormore protrusions, fingers or teeth. For example, there may be severalfinger-like protrusions 250 disposed on an upper and/or lower surface ofthe rack 232. The protrusions 250 may be angled relative to a central orlongitudinal axis of the rack 232 as shown in FIG. 35. A portion of theinner surface 124 of the main handle 10 may comprise one or morecorrespondingly shaped and/or angled protrusions or teeth 252 as shownin FIGS. 33 and 35. The angle of the teeth 252 on the inner surface ofthe main handle 10 are such that they permit the rack 232 to moveproximally forward within the main handle 10 as the user rotates theproximal suture drum 234, however, the angle and/or shape of the teeth252 on the inner surface of the handle do not permit the rack 232 tomove distally or backwards within the main handle 10. Thus, for example,the user may grip the proximal suture drum 234 and begin to rotate theproximal suture drum 234, thus pulling the rack 232 proximally withinthe main handle 10 and causing the suture to unwind from the distalsuture drum 174. Then, if the user were to release or loosen the grip onthe proximal suture drum 234, the rack 232 would not automaticallyrevert or slide back distally within the main handle 10 to its initialposition due to, for example, tension in the distal suture drum 174tending to pull the suture 180 (as well as the rack 232) backwards ordistally. In other words, the engagement between the protrusions 250 onthe rack 232 and the teeth 252 on the inner surface of the main handle10 will serve to maintain the proximal travel progress of the rack 232,and will not allow the rack 232 to slide or drift distally back withinthe main handle 10.

Maintaining the proximal travel progress of the rack 232 thereby alsomaintains the number of rotations achieved by the distal suture drum 174as well as the number or rotations of the inner cannula 22. Thus, theuser can be confident that the number of rotations accomplished by theinner cannula 22 to release the prosthesis retention mechanism (coil 84)at the proximal end 4 of the device 2 cannot unknowingly or unwittinglybecome “undone” because the rack 232 and suture 180 cannot revert ortravel distally backwards within the main handle 10 to thereby rotatethe distal suture drum 174 and inner cannula 22 in an unwanted reversedirection and possibly tangle the coil 84 with the proximal apices 66 orloops 74 of the stent graft 42.

To illustrate several non-limiting differences between the “rack”embodiment of the handle assembly 8 and the first embodiment describedherein, it can be seen that in the handle assembly 8 comprising the rack232, the suture 180 is not directly attached to the proximal suture drum234, therefore, rotation of the proximal suture drum 234 by the userdoes not cause the suture 180 to wrap around an outer surface 198 of themain handle 10 as in the previously described embodiment (see FIGS. 17and 22, where the suture 180 is attached to the proximal suture drum 162for wrapping the suture 180 around the main handle 10 at portion 198).Instead, with the addition of a rack 232 to the handle assembly 8 asdescribed herein, the proximal suture drum 162 engages directly with therack 232. As such, the proximal suture drum 162 includes threads 248 onits internal surface, such that rotation of the proximal suture drum 162by the user engages threads 240 on the rack 232 thereby pulling orurging the rack 232 forward or proximally, thereby pulling the suture180 proximally (because the suture 180 is connected to the distal end238 of the rack 232). However, proximal movement of the suture 180 dueto rotation of the proximal suture drum 234 and unwinding or the suture180 from the distal suture drum 174 to impart rotation to the distalsuture drum 174 and to the inner cannula 22 to effect release of theprosthesis retention mechanism 80 remains substantially the same.

The operation of the delivery device 2, and in particular the handleassembly 8 of the delivery device 2, will be described. In this example,use of the delivery device 2 will be described in reference to theimplantation of a stent-graft 42, such as the one shown in FIG. 3 in anaorta 254 of a patient. After an incision is made in the femoral arteryof the patient, the nose cone dilator 18 is inserted into the incisionand the device 2 is tracked over a guide wire 28 and advanced throughthe artery to the desired location, for example the abdominal aorta 254for placement of the stent-graft 42 at the site of an aneurysm, with theatraumatic tip 20 of the nose cone dilator 18 reducing the likelihood ofinjury to bodily passageways. The outer sheath 104 is disposed over thestent-graft 42 during insertion and delivery to the target site, asshown in FIGS. 1 and 13 and 43. A mechanism such as the pin vise 178 maybe used to prevent longitudinal/axial movement of the inner cannula 22during delivery to target location.

Upon proper positioning at the target site using a desired imagingmodality (i.e., by fluoroscopy, MRI, 3D or other imaging techniques) theuser grasps the gripping portion 126 of the main handle 10 with onehand, and using the other hand, grasps the second handle 12. The secondhandle 12 may be rotated relative to the main handle 10 to move thesecond handle 12 distally along the main handle 10, thereby retractingthe sheath 104 to expose at least a proximal portion of the stent-graft42. For example, the user may retract the sheath 104 to expose the topand/or seal stents 46, 56, sometimes referred to as the exposing the“diamond” at this stage of deployment as shown in FIG. 15. At thisstage, the second handle 12 has been moved distally a sufficientdistance such that the proximal suture drum 162 is also accessible andvisible to the user (see FIG. 16). The user may continue to move thesecond handle 12 distally (such as by rotating the second handle 12relative to the main handle 10) to further retract the sheath 104 untilat least a portion of the contralateral limb 58 is exposed as shown inFIG. 24.

With the stent-graft 42 at least partially exposed and the proximalsuture drum 162 (or proximal suture drum 234 in the embodiment shown inFIGS. 33-38) accessible, the proximal end 44 of the stent-graft 42 maybe deployed. As previously described, the user may rotate the proximalsuture drum 162, which winds the suture 180 around a proximal portion198 of the outer surface of the main handle 10 (or in an alternativeembodiment, rotation of the proximal suture drum 234 engages the rack232, which pulls the rack 232 proximally forward within the main handle10) which in turn, pulls the suture 180 proximally to unwind the suture180 from the distal suture drum 174. The unwinding of the suture 180from the distal suture drum 174 causes the distal suture drum 174 torotate. Rotational motion of the distal suture drum 174 is transferredto the inner cannula 22, causing the entire length of the inner cannula22 to rotate as shown in FIG. 26. Rotation of the inner cannula 22effects release of the prosthesis retention mechanism 80. For example,as the inner cannula 22 rotates, the proximal apices 66 or suture loops74 of the stent graft 42 are uncoupled from the coiled member 84 (i.e.,in a reverse manner from which the suture loops 74 were initiallycoupled to the coiled member 84 during assembly and/or manufacture). Itshould be understood by one skilled in the art that clockwise and/orcounter-clockwise rotation is merely illustrative and not limiting, andthat the handle assembly 8 and its various rotating components can bedesigned and configured to rotate in either/or a clockwise or counterclockwise direction, or combination thereof.

After release of the top stent 46, and if necessary or desired dependingon the particular procedure being performed and the condition of thepatient requiring treatment, a second guide wire 256 may be trackedthrough the contralateral leg 58 and main body 62 of the stent graft 42,to cannulate the contralateral leg 58. A second leg extension stentgraft 258 can be fed over the guide wire 256 and into position withinthe cannulated contralateral leg 58 as shown in FIG. 25. Afterdeployment of the leg extension graft 258 on the contralateral side 58,the second handle 12 may again be moved back in a distal directionrelative to the main handle 10 by the user to a position as shown inFIGS. 29 A and B to further retract the sheath 104 while simultaneouslywithdrawing one or more distal trigger wires 208 to thereby deploy theipsilateral limb 60 of the stent graft 42 as shown in FIG. 27.

To accomplish this distal trigger wire removal and deployment of thedistal end 48 of the stent graft 42, the user may continue rotation ofthe second handle 12 or, alternatively, the user may employ the “quickrelease” procedure, which permits longitudinal movement of the secondhandle 12 relative to the main handle 10 without having to rotate thesecond handle 12. Whether by continued rotation of the second handle 12relative to the main handle 10 or by implementation of the “quickrelease” procedure (allowing straight pull-back of the second handlewithout rotation), the user moves the second handle 12 distally alongthe main handle 10 for a travel distance indicated generally byreference number 212 in FIG. 28 A. In one non-limiting example, thistravel distance 212 may be the distance of longitudinal movement of thesecond handle 12 necessary to facilitate distal retraction of the sheath104 a sufficient distance to completely un-sheath the ipsilateral limb60 of the stent graft 42. By this same action, the distal trigger wireor wires 208 are also withdrawn from the distal end 48 of the prosthesis42 to complete the stent graft deployment. In the event of a mechanicalmalfunction of one or more components of the handle assembly 8 describedabove, the handle end cap 14 can be removed, and the interior 124 of themain handle 10, including the distal suture drum 174, can be accessedand rotated manually.

Once the stent graft 42 has been fully released from the delivery device2 as shown in FIG. 44, it is desirable to withdraw the delivery device 2from the patient's body. If the quick release procedure described abovehas already been employed, then the nut 142 has already been disengagedor disassociated from the main handle 10, allowing the second handle 12to slide freely longitudinally along the main handle 10. Thus, the usercan slide the second handle 12 in a proximal direction (away from theuser) on the main handle 10, thus sliding the sheath connector 108 andsheath 104 proximally and allowing the proximal end of the sheath 104 toextend over all of, part of or at least distal portion 82 of the nosecone 18 of the device 2 so as to “hub” or “recapture” a portion of thenose cone within the sheath 104 as shown in FIG. 45. Alternatively,rather than pushing the second handle 12 proximately to re-sheath thenose cone 18, the main handle 10 may be pulled distally relative to thesecond handle 12, thus pulling the distal portion 82 of the nose cone 18into the proximal end of the sheath 104. With at least a distal portion82 of the nose cone 18 recaptured within the sheath 104, the deliverydevice 2 can be withdrawn from the patient's body.

If, however, the user did not employ the quick release procedure fordistal trigger wire release (but instead the user decided to continuerotating the second handle 12 to move it distally relative to the mainhandle 10 to accomplish these deployment steps), then, at this time, thesecond handle 12 is at a distal most position on the main handle (seeFIG. 29A) but the inner surface of the nut 142 is still threadedlyengaged with the outer surface 122 of the main handle 10. Thus, in orderto move the sheath 104 proximally for tip re-sheathing or recapture, theuser must first move the ring 220 distally on the second handle 12 tomove the sleeve 222 distally, allowing the proximal end 150 of the nutto flare or expand radially outwardly and disengage from the threads 132on the main handle 10. This permits the second handle 12 to now slidefreely longitudinally on the main handle 10 and the user may then beable to move the second handle 12 proximally to recapture (re-sheath) atleast a distal portion 82 of the nose cone 18 as previously describedand shown in FIG. 45, and then remove the delivery device 2 from thepatient to complete the procedure.

1. A prosthesis delivery device having a proximal end and distal end,the prosthesis delivery device comprising: a handle assembly at thedistal end of the delivery device, the handle assembly comprising: amain handle having a proximal end and a distal end and an outer surfaceextending between the proximal and distal ends; a nut disposed on theouter surface of the main handle, the nut comprising a firstconfiguration in which the nut is engaged with the outer surface of themain handle and a second configuration in which the nut is disengagedfrom the outer surface of the main handle; a sleeve disposed about atleast a portion of the nut and longitudinally moveable relative to thenut from a proximal position to a distal position; wherein, when thesleeve is in the proximal position the nut is engaged with the outersurface of the main handle and when the sleeve is in the distal positionthe nut is disengaged from the main handle.
 2. The prosthesis deliverydevice of claim 1, wherein the nut is circumferentially disposed aboutthe main handle.
 3. The prosthesis delivery device of claim 1, whereinthe nut comprises a proximal end and a distal end and wherein theproximal end of the nut comprises a plurality of adjacent flanges. 4.The prosthesis delivery device of claim 3 wherein the flanges are biasedin a radially outwardly flared configuration when the sleeve is in thedistal position.
 5. The prosthesis delivery device of claim 3 whereinwhen the sleeve is in the proximal position the sleeve urges the flangesinto engagement with the outer surface of the main handle.
 6. Theprosthesis delivery device of claim 1 wherein the sleeve comprises aproximal end having an outer diameter and a distal end having an outerdiameter, and wherein the outer diameter of the proximal end of thesleeve is less than an outer diameter of the distal end of the sleeve.7. The prosthesis delivery device of claim 6 wherein the nut comprisesan internal surface, and wherein the proximal end of the sleeve ispositioned between the outer surface of the main handle and the internalsurface of the nut when the sleeve is in the distal position.
 8. Theprosthesis delivery device of claim 1 wherein the nut is threadedlyengaged with the outer surface of the main handle when the sleeve is inthe proximal position.
 9. The prosthesis delivery device of claim 1further comprising a second handle disposed on the main handle, thesecond handle being at least one of rotationally and longitudinallymoveable relative to the main handle.
 10. The prosthesis delivery deviceof claim 9, wherein the second handle is operatively engaged with thenut.
 11. The prosthesis delivery device of claim 9, wherein longitudinalmovement of the second handle relative to the main handle requiresrotation of the second handle when the nut is engaged with the mainhandle.
 12. The prosthesis delivery device of claim 9, furthercomprising a sheath operatively connected to the second handle andextending proximally of the main handle, wherein distal movement of thesecond handle retracts the sheath in a distal direction and whereinproximal movement of the second handle advances the sheath in a proximaldirection.
 13. The prosthesis delivery device of claim 12 whereinproximal advancement of the sheath is permitted when the nut isdisengaged from the main handle.
 14. The prosthesis delivery device ofclaim 9 further comprising an outer handle disposed about the secondhandle, the outer handle longitudinally moveable relative to the secondhandle from a proximal position to a distal position, and wherein thesleeve is operatively engaged with the outer handle.
 15. The prosthesisdelivery device of claim 14 wherein movement of the outer handle fromthe proximal position to the distal position relative to the secondhandle effects movement of the sleeve from the proximal position to thedistal position and wherein movement of the sleeve to the distalposition thereby causes the nut to disengage from the main handle. 16.The prosthesis delivery device of claim 12 further comprising a nosecone disposed at the proximal end of the device, the nose conecomprising a proximal end and a distal end, and wherein proximaladvancement of the sheath facilitates covering at least the distal endof the nose cone with the sheath.
 17. A handle assembly for a prosthesisdelivery device, the handle assembly comprising: a main handle having aproximal end and a distal end; a second handle disposed on the mainhandle and at least one of rotationally and longitudinally moveablerelative to the main handle; a release mechanism disposed within thesecond handle, the release mechanism having a first configuration inwhich the release mechanism is engaged with the main handle and a secondconfiguration in which the release mechanism is disengaged from the mainhandle; wherein the second handle must be rotated to move the secondhandle longitudinally from the proximal end to the distal end of themain handle when the release mechanism is engaged with the main handleand wherein the second handle is permitted to slide longitudinallybetween the proximal and distal ends of the main handle when the releasemechanism is disengaged from the main handle.
 18. The handle assemblyfor a prosthesis delivery device of claim 17 wherein the second handleis operatively engaged with a sheath that extends proximally from themain handle.
 19. The handle assembly for a prosthesis delivery device ofclaim 18 wherein distal movement of the second handle relative to themain handle facilitates distal retraction of the sheath and whereinproximal movement of the second handle relative to the main handlefacilitates proximal advancement of the sheath.
 20. The handle assemblyfor a prosthesis delivery device of claim 17 further comprising a sleevedisposed about at least a portion of the release mechanism andlongitudinally moveable relative to the release mechanism from aproximal position to a distal position, wherein, when the sleeve is inthe proximal position the release mechanism is engaged with the mainhandle and when the sleeve is in the distal position the releasemechanism is disengaged from the main handle.
 21. The handle assemblyfor a prosthesis delivery device of claim 20 further comprising an outerhandle disposed about the second handle, the outer handle longitudinallymoveable relative to the second handle from a proximal position to adistal position
 22. The handle assembly for a prosthesis delivery deviceof claim 21 wherein the outer handle is operatively engaged with thesleeve.
 23. The prosthesis delivery device of claim 22 wherein movementof the outer handle from a proximal position to the distal positionrelative to the second handle effects movement of the sleeve from theproximal position to the distal position and wherein movement of thesleeve to the distal position thereby causes the release mechanism todisengage from the main handle.
 24. The prosthesis delivery device ofclaim 17 wherein proximal advancement of the second handle relative tothe main handle is prevented when the release mechanism is engaged withthe main handle and wherein proximal advancement of the second handlerelative to the main handle is permitted when the release mechanism isdisengaged from the main handle.
 25. A method for releasing a prosthesisfrom a delivery device, the delivery device comprising a prosthesisreleasably coupled to the proximal end of the delivery device; a sheathcoaxially disposed about at least a portion of the prosthesis; adelivery handle assembly at a distal end of the delivery device, thedelivery handle assembly comprising a main handle, a second handledisposed about the main handle and operatively connected to the sheath,a nut disposed on an outer surface of the main handle, the nutcomprising a first configuration in which the nut is engaged with theouter surface of the main handle and a second configuration in which thenut is disengaged from the outer surface of the main handle; the methodcomprising: rotating the second handle to at least partially retract thesheath and expose at least a proximal end of the prosthesis; deployingat least the proximal end of the prosthesis; disengaging the nut fromthe main handle; retracting the second handle distally relative to themain handle to further retract the sheath and expose a distal end of theprosthesis; deploying the distal end of the prosthesis.
 26. The methodof claim 25 further comprising a sleeve disposed about at least aportion of the nut, the sleeve having a proximal position and a distalposition relative to the nut, wherein the method comprises moving thesleeve from the proximal position to the distal position therebydisengaging the nut from the main handle.
 27. The method of claim 25further comprising a nose cone located at the proximal end of thedelivery device, the method further comprising covering at least adistal portion of the nose cone with the sheath and withdrawing thedelivery device from the patient.